VALIDATION SPECIALIST

Fresenius Kabi USA, LLC
life insurance, 401(k)
United States, North Carolina, Wilson
5200 Corporate Pkwy (Show on map)
Jan 04, 2025
Job Summary The Validation Specialist works to support site validation technical experts on specific project teams. The Validation Specialist will participate in the development and execution of test plans for manufacturing equipment and processes, utilities, and facilities. The incumbent will contribute as a key validation representative in support of project team activities and process design to ensure cGMP compliance and interdepartmental consistency to the site validation master plan and strategy. Responsibilities Prepare, review, execute, and summarize validation protocols (Installation Qualification, Operational Qualification, Performance Qualification, Investigational/Development Studies) for aseptic pharmaceutical manufacturing Use of validation metrology equipment. Document validation plans and protocols (tests) to provide objective evidence that equipment, processes, and product meet requirements and are compliant with applicable regulations Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention Conduct validation testing for new products and process improvements Interact with individuals from different disciplines (Engineering, Laboratory, and Operations) to plan, execute, and complete validation activities Ensure validation efforts are conducted in an appropriate and timely manner Perform risk assessment exercises in support of validation activities Prepare Technical Packages and assessments for product transfers All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.